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Biotech / Medical : CEPH
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To: john b who wrote (558)2/4/1998 9:13:00 PM
From: WeirdPro Randy  Read Replies (2) of 998
 
<<FDA Approval>>

I feel very confident in approval after reviewing the minutes of last May's advisory panel minutes, available on the web.
The gist I get out of the meeting is that myotrophin definitely works and can actually be fairly effective in certain patients. The problems lie in the significant variety of forms and virulence of the disease process, and that certain patients will not respond positively to the drug which drags down the statistics for the overall population......this is what the "naysayers" voted upon.
The positive votes voted and voiced their opinions based on the fact that the drug does show effectiveness, and were able to look past this "dilutional effect" of patients whose disease process did not create a positive effect from the use of the drug. They voiced, to large public applause, the opinion that the lack of treatment alternatives (Rilutek as a singular treatment agent was not given much credence by anyone) creates an even greater reason why myotrophin should be approved.
With the FDA reform. and the T-IND info which creates additional data that, at least in a fair number of instances, that myotrophin has provided significant retardation of the disease...........it would be suicidal for the FDA to not approve Myotrophin!
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